Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair

NCT04089241 | Unknown

• 1 other identifier: 490-19RMB
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening condition .The most common treatment approach nowadays is the endovascular approach, a procedure known as endovascular aortic repair (EVAR). The most common procedure related complication is the expansion of the aneurysm from a "feeding vessel", usually a lumbar or intercostal artery. Another known complication is an endoleak from the stentgraft.Today, accepted EVAR follow up protocol consists of one multiple multiphasic CT angiography (CTA) scan, one month after the procedure and ultrasound exams there after . Ultrasonography is a useful method for detection and evaluation of AAA, has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR. However, the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not high.In recent years, the development of "fusion" applications allows the dual modality merge between ultrasound and CT scans that can be used as follow up examinations of known imaging findings on CT .Another application that had been developed for ultrasound machines is the ability to generate a 3 dimensional (3D) reconstruction which allows more precision. In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles (BRACO SONOVIEW) has been approved by the Israeli ministry of health. This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to Gadolinium.A 3D contrast enhanced ultrasonography "fused" together with CTA may be a helpfull addition , which lacks radiation and odine contrast reactions and nephrotoxicity ,in the follow up in post EVAR patients , by means of identifing endoleaks at an earlier stage than by ultrasound alone. The purpose of our research is to evaluate the combined modality (fusion of CTA with CEUS) mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed

Conditions

Abdominal Aortic Aneurysm; Endoleak

Outcome Measures

Primary Outcomes (1)

• Accuracy of the detection of endoleak by contrast 3D Ultrasound fused with CTA in the follow up of EVAR patients

  For each patient that will undergo the fused modality , the results of the presence or absence of endoleak and the type of the endoleak, if detected, will be compared to the gold standard CTA .

  two years

Study Arms (1)

all cohort

EXPERIMENTAL

Patients will perform CTA 1 months after the EVAR procedure. Following CTA, an ultrasound examination which will include a 3D reconstruction and CEUS will be performed using SONOVIEW contrast agent. The dimensions and volume of the aorta will be compared to the measurements in CTA using the fusion method. In the case of endoleak type 1 or 3 the patient will be urgently refered to endovascular repair . In the case of endoleak type 2 or a normal exam the patient will undergo another fused exam with CEUS at 6 month . In the case of endoleak type 2 with a growth of more than 1 cm in the aneurysm diameter , the patient will be refered to endovascular repair. In the case of a normal exam or an endoleak type 2 with a shrinkage of 1 cm or more ,the patient will undergo another fused exam with CEUS at 12 months. At any case of a new endoleak type 1 or 3 the patient will undergo CTA.

Other: Contrast 3D Ultrasound

Interventions

Contrast 3D Ultrasound OTHER

an ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent

all cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of AAA
• AAA treated endovascularly
• Patients send from the outpatient clinic to a follow up imaging study

You may not qualify if:

• AAA treated surgically and not endovascularly

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Erez Klein, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Klein, MD

CONTACT

97247772664; erezklein@gmail.com

NIra Beck-Razi, MD

CONTACT

n_beck_razi@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 13, 2019
• Study Start: September 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share